Study on the Dissolution Determination Method of Icosapent Ethyl Soft Capsules
Objective:To establish a method for determining the dissolution of Icosapent ethyl soft capsules.Methods:The paddle method(settling basket)was used with a rotation speed of 75 r·min-1,and 900 mL of hydrochloric acid solution(pH 1.2)containing 4％Triton X-100 was used as the dissolution medium.The dissolution rate at 60 minutes should not be less than 80％,which was determined by high-performance liquid chromatography using a Welch Xtimate C18(4.6 mm × 150 mm,3.5 μm)chromatographic column with acetonitrile-water(85:15)as mobile phase.The flow rate was 2.0 mL per minute,the column temperature was 30℃,the detection wavelength was 215 nm,and the injection volume was 10μL.Results:Blank excipients did not interfere;icosapent ethyl showed good linearity(r＞0.999)within the concentration range of 0.2 to 1.4mg·mL-1;the recovery rate in the medium was 98.0％-102.0％(n=9),with RSD＜2.0％and good accuracy.Both imitation and original soft capsules achieved dissolution rates over 80％within 60 minutes.Conclusion:The established method is suitable for the dissolution determination of Icosapent ethyl soft capsules and can provide reference for their quality control.
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